SAMED, with legal input, put together a collaborative set of comments from multiple stakeholder voices across the sector on the draft Medical Device Regulations. SAMED continues to support the promulgation of regulations that are appropriate for the South African market, that leverage on international experience and that of recognised jurisdictions, and which ensure speedy market access for devices.
The submission includes changes in the current draft that SAMED was aligned to, comments on the regulations that require deletion, changes and/or further discussion, comments on the regulations that have been removed that should be reinstated and regulations that should be included in this draft.
SAMED also requested for the Regulator to follow through with its commitment to hold a workshop to find alignment with industry, prior to the final publication of regulations for medical devices. We raised concerns that, without the inclusion of these recommendations and cautions, an opportunity may be missed to finalise the best possible regulatory framework.